QC Analyst - Pharmaceutical - Astrix : Job Details

Our client, a fast-growing biopharmaceutical company, is looking for a skilled QC Analyst to join their team in Middlesex County, NJ!

Position Summary

The QC Analyst will conduct and review lab tests to support product development and manufacturing. This role involves using various analytical techniques, solving problems, and ensuring tests meet quality and regulatory standards.

Salary: $80- $90K, with bonus

Location: Middlesex County, NJ

Key Responsibilities

• Perform analytical testing for in-process, release, raw material, and stability samples.
• Ensure testing is conducted in compliance with cGMP standards and ICH/regulatory guidelines.
• Participate in investigations and documentation of Out-of-Specification (OOS) results, deviations, and CAPAs.
• Collaborate with cross-functional teams on technical troubleshooting, equipment maintenance, and generation of technical reports and documentation.
• Conduct root cause analyses during lab investigations and assist in closing quality events.
• Support both internal and external audits as needed.
• Maintain adherence to all applicable company policies and procedures.
• Take on additional responsibilities as assigned.

Qualifications

• Bachelor's degree in biotechnology, biochemistry, chemistry, or a related scientific field.
• Minimum of 6+ years in an analytical laboratory operating under cGMP regulations.
• Hands-on experience with analytical methods such as: HPLC, SDS-PAGE, ELISA, capillary electrophoresis, cell-based bioassays.
• Familiarity with preparing data packages for regulatory submissions and interactions with agencies such as the FDA is preferred.

Note: This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

#INDBH